Attentional Bias Modification in Patients With Posttraumatic Stress Disorder

This study has been completed.
Sponsor:
Collaborators:
Leiden University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
PsyQ
ClinicalTrials.gov Identifier:
NCT00764101
First received: September 29, 2008
Last updated: July 7, 2011
Last verified: July 2011
  Purpose

Randomized, placebo-controlled trial of 9 sessions of computerized attentional bias training on attentional bias and on symptoms of Posttraumatic Stress Disorder.


Condition Intervention Phase
Posttraumatic Stress Disorder
Behavioral: Attentional Bias Modification
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Attentional Bias Modification on Attentional Bias and Symptoms of Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by PsyQ:

Primary Outcome Measures:
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: End of Trial + 3 week Follow-Up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PTSD symptoms (self-report) [ Time Frame: end of trial + 3wk Follow Up ] [ Designated as safety issue: No ]
  • Attentional Bias (dot-probe test) [ Time Frame: End of trial + 3wk Follow-up ] [ Designated as safety issue: No ]
  • Emotional Stroop Interference [ Time Frame: End of trial + 3wk Follow Up ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
9 sessions of attentional bias modification (computerized training program)
Behavioral: Attentional Bias Modification
computerized training to reduce attentional bias in posttraumatic stress disorder
Other Name: Attentional Training
Placebo Comparator: 2
Attentional control condition (placebo training program)
Behavioral: Attentional Bias Modification
computerized training to reduce attentional bias in posttraumatic stress disorder
Other Name: Attentional Training

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Posttraumatic Stress Disorder

Exclusion Criteria:

  • Diagnosis of psychosis, drug- or alcohol dependency/abuse;
  • Unable to fill in questionnaires in Dutch;
  • Color blindness (Stroop test).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764101

Locations
Netherlands
PsyQ Haaglanden, department of psychotrauma
Den Haag, Zuid Holland, Netherlands, 2593 HR
Sponsors and Collaborators
PsyQ
Leiden University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Study Director: Willem van der Does, professor Leiden University Medical Center
Principal Investigator: Maartje Schoorl, MS PsyQ Nederland bv
  More Information

No publications provided by PsyQ

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Willem Van der Does, PhD, Leiden University
ClinicalTrials.gov Identifier: NCT00764101     History of Changes
Other Study ID Numbers: 60-60105-98-128
Study First Received: September 29, 2008
Last Updated: July 7, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014